Closure of tissue openings, such as, for example, for surgical incisions and accidental lacerations or wounds, is critical both to minimize the risk of infection and to promote optimal healing of the wound or incision. Both of these outcomes require rapid wound closure and careful skin edge approximation. Closing a tissue opening or wound requires a mechanism for drawing both sides of a tissue opening together to promote healing and to reduce the formation of scar tissue.
Previous wound closure systems included various categories of materials passed through the skin, such as staples and sutures, substances that cover skin edges and hold them adjacent, such as glues, and adherent structures, such as strips. Common methods for closing tissue openings caused by lacerations or surgical incisions are suturing and stapling. Both of these procedures are invasive, which can traumatize and compromise the integrity of the tissue opening and the nutrient blood supply to the healing tissue edges. They cause pain, increase the possibility of infection, expose the surgeon, as well as the patient, to blood-born disease, leave behind scars, and require a follow-up visit for suture or staple removal. Surgical glue is also used, but has only been proven adequate for small wounds where skin edges are not widely separated or under tension during closure.
Surgeons have become skilled in the various techniques of suturing to minimize the resulting blemish that occurs during the healing process. These methods require a threshold of dexterity that many care providers do not possess. This is particularly true in emergency situations, which often require immediate treatment to secure the tissue opening to allow for transport or until such time as proper surgery is possible. Suturing, even by a skilled surgeon, punctures and stresses tissue causing scarring. A sutureless tissue opening closure system would be a great benefit in many situations.
Adhesive tissue closures have been introduced that can effectively close some types of tissue openings without inflicting the additional injury inherent in suturing. Adhesive closures have a backing to provide solid structure, and have an adhesive layer for adhering to the skin.
An exemplary early attempt in non-invasive wound closures used a pair of strips of fabric having adhesive backing. The strips of fabric were applied in parallel on either side of the tissue opening and were constructed with threads extending transversely to bridge the tissue opening. A compressive force was applied across the tissue opening by tying opposing ends of the transverse threads of adjacent strips.
In another device, the distal ends of the bridging threads of one adhesive strip were interconnected by another pulling strip, allowing the bridging threads to be manipulated in concert. This configuration required that the bridging threads or filaments of each of the adhesive strips be interlaced to enable the pulling strips to be pulled across the tissue opening and secured.
However, as with many prior systems, the manipulation of a loose assembly of multiple parts in an emergency and possibly life-threatening situation is a challenging undertaking.
In addition, some adhesives have been used that have utility for skin contacting applications, provide good skin compatibility, and are hydrophobic, so that they tend not to remain in the interior of tissue openings. However, their tensile strength is only sufficient for some uses, for example, for closing or sealing skin cracks, not for holding major tissue openings closed against the range of motion to which the skin or any tissue is normally subjected.
In addition to the typical wound closure devices, referred to also as devices to close a tissue opening herein, other aspects of wound closure and care have deficiencies. For example, kits for wound irrigation and closure do not allow the introduction of sterile or clean fluids before beginning a procedure. They also do not allow for different sections to be cleaned or sterilized for different parts of the procedure. Post procedural care is critical to achieve optimal healing results, but is often not properly attended to in order to minimize scarring and optimize wound healing. Currently available wound dressings are not specialized for different time periods within the healing cycle. By ignoring the changing physiology and needs of the healing wound, current dressings do not provide an optimal healing environment.
There is still a need to simplify and improve upon devices and methods for closing tissue openings and their application and provide for wound care in general.